Clinical Trial: Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

Brief Summary: The purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine.

Detailed Summary:
Sponsor: Yi Yang

Current Primary Outcome: Contrast-enhanced Transcranial Doppler [ Time Frame: within one year period ]

Patients in transcatheter closure group are required to perform contrast-enhanced Transcranial Doppler at 1 month, 3 month, 6 month and 1 year after closure, respectively.


Original Primary Outcome: Contrast-enhanced Transcranial Doppler [ Time Frame: within one year period ]

Current Secondary Outcome: Headache Impact Test-6 [ Time Frame: within one year period, at least 3 months ]

All patients complete HIT-6 score at baseline. Patients in transcatheter closure group follow-up at 1 month, 3 month, 6 month and 1 year after closure, respectively. Patients in contrast group follow-up twice during one year period.


Original Secondary Outcome: Transthoracic Echocardiography [ Time Frame: within one year period ]

Information By: First Hospital of Jilin University

Dates:
Date Received: April 29, 2014
Date Started: January 2013
Date Completion:
Last Updated: January 12, 2016
Last Verified: January 2016